22620 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

(MC2008–6, CP2008–14 and MC2008– 

15) 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 1 

(MC2008–6 and CP2009–62) 

International Business Reply Service 

Competitive Contract 1 (MC2009–14 and 

CP2009–20) 

International Business Reply Service 

Competitive Contract 2 (MC2010–18, 

CP2010–21 and CP2010–22) 

Competitive Product Descriptions 

Express Mail 

Express Mail 

Outbound International Expedited Services 

Inbound International Expedited Services 

Priority 

Priority Mail 

Outbound Priority Mail International 

Inbound Air Parcel Post 

Parcel Select 

Parcel Return Service 

International 

International Priority Airlift (IPA) 

International Surface Airlift (ISAL) 

International Direct Sacks—M-Bags 

Global Customized Shipping Services 

International Money Transfer Service 

Inbound Surface Parcel Post (at non-UPU 

rates) 

International Ancillary Services 

International Certificate of Mailing 

International Registered Mail 

International Return Receipt 

International Restricted Delivery 

International Insurance 

Negotiated Service Agreements 

Domestic 

Outbound International 

Part C—Glossary of Terms and Conditions 

[Reserved] 

Part D—Country Price Lists for International 

Mail [Reserved] 

[FR Doc. 2011–9782 Filed 4–21–11; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0102; FRL–8871–4] 

Triflusulfuron-Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triflusulfuronmethyl in or on beet, garden, roots and 

beet, garden, tops. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

22, 2011. Objections and requests for 

hearings must be received on or before 

June 21, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0102. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0102 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 21, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0102, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 22621 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of March 19, 

2010 (75 FR 13277) (FRL–8813–2), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7669) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.492 be 

amended by establishing tolerances for 

residues of the herbicide triflusulfuronmethyl, 2-[[[[[4-(dimethylamino)-6- 

(2,2,2-trifluoroethoxy)-1,3,5-triazin-2- 

yl]amino]carbonyl]amino]sulfonyl]-3- 

methylbenzoate, in or on beet, garden, 

roots at 0.01 parts per million (ppm); 

and beet, garden, tops at 0.02 ppm. That 

notice referenced a summary of the 

petition prepared on behalf of IR–4 by 

DuPont Crop Protection, the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

EPA has revised the tolerance 

expression for all established 

commodities to be consistent with 

current Agency policy and has made a 

technical correction to the chemical 

name. The reasons for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for triflusulfuronmethyl, including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with triflusulfuronmethyl follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Triflusulfuron-methyl is of low acute 

toxicity when administered orally, 

dermally, or via inhalation. It is not a 

dermal sensitizer or irritant, and causes 

only minor transient irritation to the 

eye. The primary target organs 

identified for triflusulfuron-methyl are 

the liver, testes, and red blood cells. 

Hematological and histopathological 

changes consistent with mild hemolytic 

anemia were observed in the rat and the 

dog. Following subchronic and/or 

chronic dietary exposure, increased 

incidence of testicular interstitial 

hyperplasia was observed in the rat, and 

testicular atrophy and reduced size were 

observed in the dog. Liver effects 

including histopathology and increased 

weight were observed in the dog and 

mouse, but not in the rat. 

No evidence of neurotoxicity was 

observed except for a statistically 

significant increase in sciatic nerve 

myelin/axon degeneration in female rats 

at the highest dose tested in the rat 

combined chronic toxicity/ 

carcinogenicity study. However, the 

incidence was high in all dose groups, 

no increases were seen in the interim 

sacrifice groups or in shorter-term 

studies, and it is commonly observed in 

older rats. 

In the rat developmental toxicity 

study, no developmental effects were 

noted, whereas maternal toxicity was 

observed (decreased body weight gain, 

food consumption and feed efficiency). 

Abortions occurred in the rabbit 

developmental toxicity study at a dose 

that also caused significant maternal 

toxicity, including mortality, clinical 

signs, sharply reduced food 

consumption and decreased weight 

gain. In the rat reproductive toxicity 

study, decreased parental body weight/ 

weight gain and offspring weight during 

lactation were observed at the mid and 

high doses. No reproductive effects were 

observed. 

Triflusulfuron-methyl is classified as 

a possible human carcinogen (Group C) 

under the 1986 Cancer Guidelines, 

based on an increased incidence of 

benign testicular interstitial cell 

adenomas in male rats in the combined 

chronic/carcinogenicity toxicity study 

and evidence of clastogenicity in some 

in vitro genotoxicity studies. A special 

mechanistic study that evaluated 

hormonal changes in male rats provided 

insufficient information to establish a 

nonlinear mode of action for the 

formation of these tumors. Additionally, 

although a statistically significant 

incidence of hepatocellular adenomas 

was noted in a carcinogenicity study in 

mice, it was within the historical 

control range and not considered as part 

of the weight-of-evidence for 

determination of cancer classification. 

Because the observed tumors were 

benign and found in only one species, 

and only at significantly higher dose 

levels than the dose selected for the 

point of departure, the chronic reference 

dose (RfD) is considered protective of 

potential carcinogenicity for risk 

assessment purposes. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triflusulfuron-methyl 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Triflusulfuron-methyl: 

Revised Human Health Risk Assessment 

for Use in Garden Beet.’’ at pages 34–38 

in docket ID number EPA–HQ–OPP– 

2010–0102. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

RfD—and a safe margin of exposure 


erowe on DSK5CLS3C1PROD with RULES
22622 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 

(MOE). For non-threshold risks, the 

Agency assumes that any amount of 

exposure will lead to some degree of 

risk. Thus, the Agency estimates risk in 

terms of the probability of an occurrence 

of the adverse effect expected in a 

lifetime. For more information on the 

general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. A 

summary of the toxicological endpoints 

for triflusulfuron-methyl used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLUSULFURON-METHYL FOR USE IN HUMAN

HEALTH RISK ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–49 years of age 

and General population, including infants 

and children).

Not required. An appropriate endpoint for this risk assessment was not identified. 

Chronic dietary (All populations) ...................... NOAEL= 2.44 mg/kg/ 

day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.0244 

mg/kg/day. 

cPAD = 0.0244 mg/kg/ 

day. 

Chronic oral toxicity/carcinogenicity in the rat 

LOAEL = 30.6 mg/kg/day based on decreased body weight/weight gain, 

hematological changes (primarily males) 

and increased interstitial cell hyperplasia 

(males). 

Cancer (Oral, dermal, inhalation) ..................... Classification: Possible Human Carcinogen (Group C, 1986 Cancer Guidelines), based on increased incidence of testicular interstitial cell adenomas in rats. The RfD is considered adequately protective of these effects. 

FQPA SF = Food Quality Protection Act Safety Factor. 

PAD = population adjusted dose (a = acute, c = chronic). 

UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to triflusulfuron-methyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing triflusulfuron-methyl tolerances 

in 40 CFR 180.492. EPA assessed dietary 

exposures from triflusulfuron-methyl in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for triflusulfuron-methyl; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 1994– 

1996 and 1998 Continuing Surveys of 

Food Intakes by Individuals (CSFII). As 

to residue levels in food, EPA utilized 

tolerance-level residues and 100 percent 

crop treated (PCT) for all commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that the use of the chronic 

RfD is considered protective of potential 

carcinogenicity for risk assessment 

purposes. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for triflusulfuron-methyl. Tolerance 

level residues and/or 100 PCT were 

assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for triflusulfuron-methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of triflusulfuron-methyl. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

triflusulfuron-methyl for chronic 

exposures for non-cancer assessments 

are estimated to be 0.005 parts per 

billion (ppb) for surface water and 

0.50 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.50 ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Triflusulfuron-methyl is not registered 

for any specific use patterns that would 

result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 22623 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found triflusulfuron-methyl to share a 

common mechanism of toxicity with 

any other substances, and triflusulfuronmethyl does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that triflusulfuron-methyl does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The triflusulfuron-methyl toxicity 

database is adequate to evaluate 

potential increased susceptibility of 

infants and children, and includes 

developmental toxicity studies in rat 

and rabbit and a 2-generation toxicity 

study in rat. No developmental effects 

were seen in the rat developmental 

toxicity study. In the rabbit 

developmental toxicity study, abortions 

were observed at a dose that also caused 

significant maternal toxicity, including 

mortality, clinical signs, sharply 

reduced food consumption and 

decreased weight gain. In the rat 

2-generation reproductive toxicity 

study, decreased parental body weight/ 

weight gain and F1 pup weight during 

lactation were observed at the mid and 

high doses. No reproductive effects were 

observed. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

triflusulfuron-methyl is complete except 

for immunotoxicity testing. Recent 

changes to 40 CFR part 158 require 

immunotoxicity testing (OPPTS 

Guideline 870.7800) for pesticide 

registration. However, the existing data 

are sufficient for endpoint selection for 

exposure/risk assessment scenarios, and 

for evaluation of the requirements under 

the FQPA. There was no evidence of 

direct immunotoxicity in the available 

studies. Hemolytic anemia, an effect 

associated with exposure to some 

sulfonylurea compounds, was observed 

for triflusulfuron-methyl. Immunemediated hemolysis following binding 

to red blood cells has been reported for 

sulfonylurea drugs such as 

chlorpromamide, although it is not clear 

that the hemolytic anemia observed 

with triflusulfuron-methyl is related to 

the immune system. However, the 

hemolytic effects seen in the studies 

were of low concern because the effects 

were sporadic and marginal (< 10% 

below controls) and a large margin of 

safety for the effects was provided by 

the selection of the PODs. In the rat, 

significant hematological alterations and 

regenerative changes were observed at 

doses ≥ 100-fold above the selected 

PODs. Effects in the dog were seen at 

doses ≥ 15-fold higher. The Agency does 

not believe that an immunotoxicity 

study will provide a POD lower than 

that currently used for risk assessment; 

therefore, an additional UF is not 

needed to account for the lack of this 

study. 

ii. Although a statistically significant 

increase in sciatic nerve myelin/axon 

degeneration in high dose female rats 

was observed in the triflusulfuronmethyl rat combined chronic toxicity/ 

carcinogenicity study, the incidence 

was high in all dose groups, no 

increases were seen in the interim 

sacrifice groups or in shorter-term 

studies, and the lesion is commonly 

observed in older rats. Therefore, EPA 

did not consider this finding to be 

evidence of frank neurotoxicity, and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

triflusulfuron-methyl results in 

increased susceptibility in in utero rats 

or rabbits in the prenatal developmental 

studies or in young rats in the 

2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

triflusulfuron-methyl in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by triflusulfuron-methyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, triflusulfuronmethyl is not expected to pose an acute 

risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to triflusulfuronmethyl from food and water will utilize 

< 1% of the cPAD for children 3–5 years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for triflusulfuronmethyl. Therefore, the chronic aggregate 

risk estimates are equivalent to the 

chronic dietary (food + water) risk 

estimates. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, triflusulfuronmethyl is not registered for any use 

patterns that would result in short- or 

intermediate-term residential exposure. 

Short- and intermediate-term risk is 

assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short- and 

intermediate-term risk), no further 

assessment of short- and intermediateVerDate Mar<15>2010 14:51 Apr 21, 2011 Jkt 223001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\22APR1.SGM 22APR1

erowe on DSK5CLS3C1PROD with RULES
22624 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 

term risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for triflusulfuron-methyl. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.C.iii., the chronic dietary risk 

assessment is protective of any potential 

cancer effects. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

triflusulfuron-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high-performance liquid 

chromatography with ultraviolet 

detection (HPLC–UV) method (Method 

AMR 1930–91), is available to enforce 

the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

There are currently no Codex MRLs 

established for residues of 

triflusulfuron-methyl in or on 

commodities associated with this 

petition. However, this action was a 

work share agreement with Canada’s 

Pesticide Management Regulatory 

Agency (PMRA). While the tolerance for 

beet, garden, roots at 0.01 ppm is 

harmonized with PMRA, the tolerance 

for beet, garden, tops at 0.02 ppm is not 

harmonized with PMRA’s MRL of 0.01 

ppm for that commodity. Based on the 

submitted residue data, garden beet tops 

had residue levels equal to 0.01 ppm; 

given the level of uncertainty for 

quantification around the limit of 

quantitation (0.01 ppm), EPA has 

determined that a tolerance for beet, 

garden, tops at 0.02 ppm is appropriate. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that made a general 

objection to the presence of any 

pesticide residues on crops and stated 

that EPA should set no pesticide 

tolerance greater than zero. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) states that tolerances may 

be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the tolerance 

expression to clarify: (1) That, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of triflusulfuron-methyl not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

Additionally, EPA has revised the 

chemical name from triflusulfuron 

methyl to triflusulfuron-methyl in order 

to reflect the preferred common name of 

the chemical. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triflusulfuron-methyl, 

(methyl 2-[[[[[4-(dimethylamino)-6- 

(2,2,2-trifluoroethoxy)-1,3,5-triazin-2- 

yl]amino]carbonyl]amino]sulfonyl]-3- 

methylbenzoate), in or on beet, garden, 

roots at 0.01 ppm; and beet, garden, tops 

at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 22625 

1See unclassified summary at: http:// 

www.dhs.gov/xoig/assets/mgmtrpts/OIG_05- 

51_Sep05.pdf. 

2See http://www.tsa.gov/what_we_do/tsnm/ 

general_aviation/ 

programs_sp.shtm#general_aviation for more 

information on the General Aviation Secure 

Program. 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 15, 2011. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.492 is amended by 

revising the section heading and 

paragraph (a) introductory text and 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.492 Triflusulfuron-methyl; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of 

triflusulfuron-methyl, including its 

metabolites and degradates, in or on the 

commodities listed in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only triflusulfuron-methyl 

(methyl 2-[[[[[4-(dimethylamino)-6- 

(2,2,2-trifluoroethoxy)-1,3,5-triazin-2- 

yl]amino]carbonyl]amino]sulfonyl]-3- 

methylbenzoate) in or on the following 

commodities: 

Commodity Parts per 

million 

Beet, garden, roots ................... 0.01 

Beet, garden, tops .................... 0.02 

Commodity Parts per 

million 

*****

* * * * * 

[FR Doc. 2011–9849 Filed 4–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

49 CFR Part 1503 

[Docket No. TSA–2009–0014; Amendment 

No. 1503–4] 

RIN 1652–AA66 

Reporting of Security Issues 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: Final rule. 

SUMMARY: The Transportation Security 

Administration (TSA) is adding 

procedures by which any person will 

receive a receipt for reporting a 

problem, deficiency, or vulnerability 

related to transportation security, 

including the security of aviation, 

maritime, railroad, motor carrier 

vehicle, or pipeline transportation, or 

any mode of public transportation, such 

as mass transit, in accordance with the 

‘‘Implementing Recommendations of the 

9/11 Commission Act of 2007’’ (9/11 

Act). 

DATES: Effective May 23, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Traci Klemm, Office of Chief Counsel, 

TSA–2, Transportation Security 

Administration, 601 South 12th Street, 

Arlington, VA 20598–6002; telephone 

(571) 227–3596; facsimile (571) 227– 

1380; e-mail traci.klemm@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Availability of Rulemaking Document 

You can get an electronic copy using 

the Internet by— 

(1) Searching the electronic Federal 

Docket Management System (FDMS) 

Web page at http://www.regulations.gov; 

(2) Accessing the Government 

Printing Office’s Web page at http:// 

www.gpoaccess.gov/fr/index.html; or 

(3) Visiting TSA’s Security 

Regulations Web page at http:// 

www.tsa.gov and accessing the link for 

‘‘Research Center’’ at the top of the page. 

In addition, copies are available by 

writing or calling the person in the FOR

FURTHER INFORMATION CONTACT section. 

Make sure to identify the docket number 

of this rulemaking. 

Small Entity Inquiries 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires TSA to comply with small 

entity requests for information and 

advice about compliance with statutes 

and regulations within TSA’s 

jurisdiction. Any small entity that has a 

question regarding this document may 

contact the person listed in FOR FURTHER

INFORMATION CONTACT. Persons can 

obtain further information regarding 

SBREFA on the Small Business 

Administration’s Web page at http:// 

www.sba.gov/advo/laws/law_lib.html. 

Background 

In the immediate aftermath of the 

events on September 11, 2001, the 

Federal Aviation Administration (FAA) 

established a task force to respond to the 

large volume of incoming phone calls, 

e-mails, and letters from the public. On 

June 1, 2002, the Transportation 

Security Administration (TSA) assumed 

responsibility for this response to the 

public, creating what is now known as 

the TSA Contact Center (TCC). The TCC 

is a widely-publicized open line for the 

public to contact TSA. As such, it has 

also provided a mechanism through 

which TSA may receive information 

about potential threats to transportation 

security from both well-meaning 

persons and those with harmful intent. 

In December 2004, TCC availability 

was expanded to 24 hours a day, 7 days 

a week, 365 days per year, primarily to 

ensure continuous review for threatrelated contacts. The current process for 

public reporting of potential security 

violations, threat information or 

criminal activities, vulnerabilities and 

intelligence was put in place after the 

DHS Office of Inspector General 

assessed the Agency’s actions to 

improve the handling of threat and nonthreat communications following an 

incident where a college student was 

testing security.1

TSA also has ongoing initiatives 

within the various transportation 

modes, such as the General Aviation 

Secure Program, that includes hotline 

numbers to alert TSA of security 

concerns.2 Information from these 

reporting options, along with reports of 

other security incidents and concerns 

required by various TSA regulations, is 

received and processed by the same 

analytical components of TSA. Through 


erowe on DSK5CLS3C1PROD with RULES